Dosage form Design: Dissolution, Bioequivalence and if biowaiver can be applied

6th December 2016,
London, United Kingdom

In the pharmaceutical industry, formulation scientists are very well educated and experienced according to their merit in the dosage form design to include formulation development, method of analysis, kinetics and stability… etc ensuring compliance with the guideline requirements covering module 3 of the CTD.
However, the clinical side concerning the bioavailability/bioequivalence studies covered in Module 5 of the dossier are usually designed and carried out by a different team of clinical background and experience. The clinical team might not be directly involved in the dosage form design from start and have not gained sufficient experience to positively contribute in the studies covering formulation factors effecting the bioavailability performance of the finished product.
This difference in the background and experience or even orientation between the two different teams within the same pharmaceutical establishment have created a gap in understanding each sides requirements and limitations.
Interestingly this difference and the gap identified in the understanding of the requirements of the quality of the finished product and its design linked to the bioavailability/bioequivalence performance have been relatively demonstrated to a certain extent in the guidelines published and their main scope.
For example, concerning modified release products, two different guidelines have been recently published by EMA with different scopes. One is covering the quality side (Guideline on quality of oral modified release products, EMA/CHMP/QWP/428693/2013published in March 2014)
Whilst the other is covering pharmacokinetics and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) published November 2014:

The aim of this workshop is an attempt to fill this gap by linking the quality of the concerned dosage form expressed in terms of dissolution behaviour with its bioavailability/bioequivalence performance required by the guidance.
Two case studies will be presented when the competent authority in EU had intervened requesting further information to justify the biowaiver claim made.

Masterclass
LEADER

Muhaned Al-Hindawi

Dr Muhaned Al-hindawi The managing director and principal
consultant of “Ontargetpharma Consultancy”, London UK.
Worked as a Senior Pharmaceutical Assessor with MHRA.
During work in MHRA made a number of break-through issues.
Among those are: The dissolution performance of multiplestrengths
of oral solid dosage forms and how biowaiver can
be applied and effect of excipient on the bioavailability of API from oral
solution and biowaiver criteria. Occupied a number of technical posts in
the pharmaceutical industry with over 15 years of hand on experience in
many areas. This includes new product development, method of analysis
construction and process validation. Involved in a number of high profi le
projects including a joint project between Jordan and EU, upgrading the
Jordanian pharmaceutical manufacturing companies to comply with the
European standards and levels. Prior to joining the pharmaceutical industry,
worked in a number of research and academic institutions whereby a
number of publications have been made

Ontarget pharma Consultancy

Ontarget pharma Consultancy is a leading pharmaceutical consulting company based in London, UK. The aim is to provide a high standard of pharmaceutical consultancy covering the areas of regulatory affairs and technical requirements governed by the current Directives and guidance for marketing authorisation of medicinal products in UK and rest of EU.
Detail of the services provided can be seen by browsing the company’s website www.ontargetpharma.com

Masterclass
programme

8:30 Registration & Coffee

9:00 Critical review of guidance on the quality and bioequivalence of immediate release preparations.

Dr Muhaned Al-hindawi The managing director and principal
consultant of “Ontargetpharma Consultancy”, London UK.
Worked as a Senior Pharmaceutical Assessor with MHRA.
During work in MHRA made a number of break-through issues.
Among those are: The dissolution performance of multiplestrengths
of oral solid dosage forms and how biowaiver can
be applied and effect of excipient on the bioavailability of API from oral
solution and biowaiver criteria. Occupied a number of technical posts in
the pharmaceutical industry with over 15 years of hand on experience in
many areas. This includes new product development, method of analysis
construction and process validation. Involved in a number of high profi le
projects including a joint project between Jordan and EU, upgrading the
Jordanian pharmaceutical manufacturing companies to comply with the
European standards and levels. Prior to joining the pharmaceutical industry,
worked in a number of research and academic institutions whereby a
number of publications have been made

11:30 Morning Coffee

11:50 Critical review of guidance on the quality and bioequivalence of prolonged release products.

Dr Muhaned Al-hindawi The managing director and principal
consultant of “Ontargetpharma Consultancy”, London UK.
Worked as a Senior Pharmaceutical Assessor with MHRA.
During work in MHRA made a number of break-through issues.
Among those are: The dissolution performance of multiplestrengths
of oral solid dosage forms and how biowaiver can
be applied and effect of excipient on the bioavailability of API from oral
solution and biowaiver criteria. Occupied a number of technical posts in
the pharmaceutical industry with over 15 years of hand on experience in
many areas. This includes new product development, method of analysis
construction and process validation. Involved in a number of high profi le
projects including a joint project between Jordan and EU, upgrading the
Jordanian pharmaceutical manufacturing companies to comply with the
European standards and levels. Prior to joining the pharmaceutical industry,
worked in a number of research and academic institutions whereby a
number of publications have been made

12:30 Critical review of guidance on the quality and bioequivalence of gastro-resistant products

Dr Muhaned Al-hindawi The managing director and principal
consultant of “Ontargetpharma Consultancy”, London UK.
Worked as a Senior Pharmaceutical Assessor with MHRA.
During work in MHRA made a number of break-through issues.
Among those are: The dissolution performance of multiplestrengths
of oral solid dosage forms and how biowaiver can
be applied and effect of excipient on the bioavailability of API from oral
solution and biowaiver criteria. Occupied a number of technical posts in
the pharmaceutical industry with over 15 years of hand on experience in
many areas. This includes new product development, method of analysis
construction and process validation. Involved in a number of high profi le
projects including a joint project between Jordan and EU, upgrading the
Jordanian pharmaceutical manufacturing companies to comply with the
European standards and levels. Prior to joining the pharmaceutical industry,
worked in a number of research and academic institutions whereby a
number of publications have been made

13:00 Networking Lunch

14:00 Two case studies in which the competent authority in EU had intervened requesting further information to justify the biowaiver request made:

Dr Muhaned Al-hindawi The managing director and principal
consultant of “Ontargetpharma Consultancy”, London UK.
Worked as a Senior Pharmaceutical Assessor with MHRA.
During work in MHRA made a number of break-through issues.
Among those are: The dissolution performance of multiplestrengths
of oral solid dosage forms and how biowaiver can
be applied and effect of excipient on the bioavailability of API from oral
solution and biowaiver criteria. Occupied a number of technical posts in
the pharmaceutical industry with over 15 years of hand on experience in
many areas. This includes new product development, method of analysis
construction and process validation. Involved in a number of high profi le
projects including a joint project between Jordan and EU, upgrading the
Jordanian pharmaceutical manufacturing companies to comply with the
European standards and levels. Prior to joining the pharmaceutical industry,
worked in a number of research and academic institutions whereby a
number of publications have been made

-Effect of excipient on the bioavailability of the API from aqueous oral solution and biowaiver criteria
-Composition proportionality & dissolution similarity of multiple strengths formulations of oral solid dosage forms

15:00 Afternoon Tea

15:20 Panel Discussion

Dr Muhaned Al-hindawi The managing director and principal
consultant of “Ontargetpharma Consultancy”, London UK.
Worked as a Senior Pharmaceutical Assessor with MHRA.
During work in MHRA made a number of break-through issues.
Among those are: The dissolution performance of multiplestrengths
of oral solid dosage forms and how biowaiver can
be applied and effect of excipient on the bioavailability of API from oral
solution and biowaiver criteria. Occupied a number of technical posts in
the pharmaceutical industry with over 15 years of hand on experience in
many areas. This includes new product development, method of analysis
construction and process validation. Involved in a number of high profi le
projects including a joint project between Jordan and EU, upgrading the
Jordanian pharmaceutical manufacturing companies to comply with the
European standards and levels. Prior to joining the pharmaceutical industry,
worked in a number of research and academic institutions whereby a
number of publications have been made

16:00 Closing remarks

Dr Muhaned Al-hindawi The managing director and principal
consultant of “Ontargetpharma Consultancy”, London UK.
Worked as a Senior Pharmaceutical Assessor with MHRA.
During work in MHRA made a number of break-through issues.
Among those are: The dissolution performance of multiplestrengths
of oral solid dosage forms and how biowaiver can
be applied and effect of excipient on the bioavailability of API from oral
solution and biowaiver criteria. Occupied a number of technical posts in
the pharmaceutical industry with over 15 years of hand on experience in
many areas. This includes new product development, method of analysis
construction and process validation. Involved in a number of high profi le
projects including a joint project between Jordan and EU, upgrading the
Jordanian pharmaceutical manufacturing companies to comply with the
European standards and levels. Prior to joining the pharmaceutical industry,
worked in a number of research and academic institutions whereby a
number of publications have been made

16:30 End of workshop

Supporters

View detailsEIN NewsSupportershttp://www.einnews.comEIN News is the world leader in industry focused online news monitoring. Thousands of leading companies, institutions and global professionals from business, industry, and government rely on EIN News as an indispensable resource. Our systems continuously scan the web, indexing news from thousands of worldwide sources. The news you need is then organized by advanced software systems managed by a team of professional news editors. Everything we do is focused on streamlining your news searches and research in order to save you time and money.

Media Partners

EIN News

EIN News is the world leader in industry focused online news monitoring. Thousands of leading companies, institutions and global professionals from business, industry, and government rely on EIN News as an indispensable resource. Our systems continuously scan the web, indexing news from thousands of worldwide sources. The news you need is then organized by advanced software systems managed by a team of professional news editors. Everything we do is focused on streamlining your news searches and research in order to save you time and money.

Holiday Inn Kensington Forum

97 Cromwell Road
London SW7 4DN
United Kingdom

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington.

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow.

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel.

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event.

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee.

Cookie Policy

From May 2011 a new privacy law came into effect across the EU. The law requires
that websites ask visitors for consent to use most web cookies. We use cookies to
ensure you get the best experience on our website –Tick here to accept cookie use
Details of our cookie use may be found here.

WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy,
which maintains that in order to be effective, learning should be organised and
structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional
competence’

CPD is a common requirement of individual membership with professional bodies and
Institutes. Increasingly, employers also expect their staff to undertake regular
CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do
not become obsolete, and allows for best practice and professional standards to
be upheld.

CPD can be undertaken through a variety of learning activities including instructor
led training courses, seminars and conferences, e:learning modules or structured
reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with
a collective membership of circa 4 million professionals, and they all expect their
members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked
to a licence to practice, for others it’s obligatory. By ensuring that their members
undertake CPD, the professional bodies seek to ensure that professional standards,
legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide
online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’
or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve
within a given time period. These schemes can also use different ‘currencies’ such
as points, merits, units or credits, where an individual must accumulate the number
required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of
learning.

‘Output’ based schemes are learner centred. They require individuals to set learning
goals that align to professional competencies, or personal development objectives.
These schemes also list different ways to achieve the learning goals e.g. training
courses, seminars or e:learning, which enables an individual to complete their CPD
through their preferred mode of learning.

As a formal provider of CPD certified activities, SMI Group can provide an indication
of the learning benefit gained and the typical completion. However, it is ultimately
the responsibility of the delegate to evaluate their learning, and record it correctly
in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces
and looking to the UK to benchmark educational standards. The undertaking of CPD
is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk